SFDA--Business Guide--Drug Registration Website

http://www.sfda.gov.cn/cmsweb/webportal/W45649089/index.html  

Posted by aspantev on 2007-11-13 09:25:03
Filed under Favori_Assen | Comments (1)

Public Reviews and Comments

http://www.sfda.gov.cn/cmsweb/webportal/W45649089/index.html overall webpage rating:

Reviews to date: 1 . Page 1 of 1.

ramesh paear   Mumbai 

  Posted at 3:24am on Thursday, June 12th, 2008

Accelerated stability testing on two batches should be conducted, one of which must be
either commercial batch or a pilot-scale batch. A pilot batch should not be smaller than one
eighth of the commercial batch. If accelerated stability testing was carried out on one
laboratory batch, which was produced by similar manufacturing process and has the same
composition of active ingredient/s and excipient/s as for the commercial batch, accelerated
stability test on single commercial or pilot-scale batch should be acceptable. Accelerated
stability testing should be done on 0, 3 and 6 months.


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